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Gastrointestinal CancerPhase 1/2NCT06596694

Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

A Phase 1/2 study testing Patritumab deruxtecan in people with Gastrointestinal Cancer, run by Merck Sharp & Dohme LLC at 62 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Cancer
What is being tested?
Patritumab deruxtecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
62 sitesin 15 countries
Study dates
3 Nov 2024to 7 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Has one of the following cancers:
  • Unresectable or metastatic colorectal cancer.
  • Advanced and/or unresectable biliary tract cancer (BTC)
  • Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
  • Locally advanced unresectable or metastatic gastroesophageal cancer
  • Has received prior therapy for the cancer.
  • Has recovered from any side effects due to previous cancer treatment

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
  • Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
  • Has evidence of any leptomeningeal disease
  • Has clinically significant corneal disease
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection

Trial locations and contacts

62 sites in 15 countries.

62 sites in 15 countries

United States13 sites

  • University of Colorado Cancer Center ( Site 1200)

    Aurora, Colorado, 80045

  • University of Chicago Medical Center ( Site 1204)

    Chicago, Illinois, 60637

  • University of Florida ( Site 1202)

    Gainesville, Florida, 32610

  • University of Wisconsin ( Site 1210)

    Madison, Wisconsin, 53792

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)

    Marietta, Georgia, 30060

  • Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)

    Miami Beach, Florida, 33140

  • NYU Langone Hospital - Long Island ( Site 1230)

    Mineola, New York, 11501

  • Perlmutter NYU Cancer Center ( Site 1212)

    New York, New York, 10016

  • Renown Regional Medical Center ( Site 1221)

    Reno, Nevada, 89502

  • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)

    Roanoke, Virginia, 24014

  • UCLA Hematology Oncology Santa Monica ( Site 1205)

    Santa Monica, California, 90404

  • Scott & White Medical Center-Temple ( Site 1224)

    Temple, Texas, 76508

  • Sibley Memorial Hospital ( Site 1208)

    Washington D.C., District of Columbia, 20016

Other trials in United States

China9 sites

  • Fujian Provincial Cancer Hospital ( Site 0408)

    Fuzhou, Fujian, 350014

  • Southern Medical University Nanfang Hospital ( Site 0413)

    Fuzhou, Guangdong, 510515

  • The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Anhui Medical University ( Site 0405)

    Hefei, Anhui, 230088

  • Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)

    Nanning, Guangxi, 530200

  • Zhongshan Hospital,Fudan University ( Site 0400)

    Shanghai, Shanghai Municipality, 200032

  • First Hospital of Shanxi Medical University ( Site 0409)

    Taiyuan, Shanxi, 030001

  • Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)

    Xiamen, Fujian, 361015

  • Henan Cancer Hospital ( Site 0403)

    Zhengzhou, Henan, 450008

Other trials in China

Australia4 sites

  • Alfred Health ( Site 0102)

    Melbourne, Victoria, 3004

  • Austin Health ( Site 0103)

    Melbourne, Victoria, 3084

  • One Clinical Research ( Site 0104)

    Mount Pleasant, Western Australia, 6009

  • Westmead Hospital ( Site 0100)

    Sydney, New South Wales, 2145

Other trials in Australia

Chile4 sites

  • Fundacion Arturo Lopez Perez ( Site 0301)

    Santiago, Region M. de Santiago, 7500921

  • Centro de Oncología de Precisión ( Site 0305)

    Santiago, Region M. de Santiago, 7560908

  • Clínica UC San Carlos de Apoquindo ( Site 0302)

    Santiago, Region M. de Santiago, 7620002

  • Bradfordhill ( Site 0300)

    Santiago, Region M. de Santiago, 8420383

Other trials in Chile

South Korea4 sites

  • Seoul National University Hospital ( Site 0900)

    Seodaemun-gu, Seoul, 03080

  • Severance Hospital, Yonsei University Health System ( Site 0903)

    Seoul, 03722

  • Asan Medical Center ( Site 0902)

    Seoul, 05505

  • Samsung Medical Center ( Site 0901)

    Seoul, 06351

Other trials in South Korea

Spain4 sites

  • Hospital Universitari Vall d Hebron ( Site 1000)

    Barcelona, 08035

  • Hospital Universitario Gregorio Maranon ( Site 1002)

    Madrid, 28007

  • Hospital Clinico San Carlos... ( Site 1003)

    Madrid, 28040

  • Hospital Central de Asturias ( Site 1001)

    Oviedo, Principality of Asturias, 33011

Other trials in Spain

Turkey (Türkiye)4 sites

  • Adana City Hospital ( Site 1404)

    Adana, 01370

  • Hacettepe Universite Hastaneleri ( Site 1401)

    Ankara, 06230

  • Dokuz Eylul Universitesi Hastanesi ( Site 1402)

    Balçova, İzmir, 35340

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)

    Yenimahalle, Ankara, 06200

Other trials in Turkey (Türkiye)

Canada3 sites

  • QEII Health Sciences Centre - Victoria General Site ( Site 0200)

    Halifax, Nova Scotia, B3H 2Y9

  • McGill University Health Centre ( Site 0202)

    Montreal, Quebec, H4A 3J1

  • Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)

    Toronto, Ontario, M4N 3M5

Other trials in Canada

France3 sites

  • Hopital Beaujon ( Site 0500)

    Clichy, Hauts-de-Seine, 92110

  • Hopital de la Croix Rousse ( Site 0502)

    Lyon, Auvergne-Rhône-Alpes, 69004

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)

    Rennes, Ille-et-Vilaine, 35042

Other trials in France

Israel3 sites

  • Rambam Health Care Campus ( Site 0603)

    Haifa, 3109601

  • Hadassah Medical Center ( Site 0602)

    Jerusalem, 9112001

  • Sourasky Medical Center ( Site 0601)

    Tel Aviv, 6423906

Other trials in Israel

Italy3 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

    Milan, 20133

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

    Milan, 20162

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)

    Roma, 00168

Other trials in Italy

Taiwan3 sites

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)

    Tainan, 704

  • National Taiwan University Hospital ( Site 1500)

    Taipei, 10002

  • Taipei Veterans General Hospital ( Site 1501)

    Taipei, 112201

Other trials in Taiwan

Switzerland2 sites

  • Hopitaux Universitaires de Geneve HUG. ( Site 1102)

    Geneva, 1211

  • Universitaetsspital Zuerich ( Site 1105)

    Zurich, 8091

Other trials in Switzerland

Thailand2 sites

  • Faculty of Medicine Siriraj Hospital ( Site 1301)

    Bangkoknoi, Bangkok, 10700

  • Ramathibodi Hospital ( Site 1302)

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

New Zealand1 site

  • Harbour Cancer & Wellness ( Site 0800)

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn:

  • About the safety and how well people tolerate of patritumab deruxtecan
  • How many people have the cancer respond (get smaller or go away) to treatment
Being tested
Patritumab deruxtecan
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patritumab deruxtecanBiological

    Also called MK-1022, HER3-DXd, U3-1402

    Administered via intravenous (IV) infusion

Study groups in NCT06596694
Study groupRoleWhat they receive
Patritumab deruxtecanExperimentalParticipants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
Receives: Biological: Patritumab deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)

    DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented.

    Measured: Up to 21 days

  2. Number of Participants with One or More Adverse Events (AEs)

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.

    Measured: Up to approximately 44 months

  3. Number of Participants who Discontinue Study Intervention Due to an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to approximately 44 months

  4. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 44 months

Secondary outcomes (5)

  1. Duration of Response (DOR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 44 months

  2. Progression Free Survival (PFS)

    PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 44 months

  3. Overall Survival (OS)

    OS is the length of time from when the participant starts treatment until death from any cause.

    Measured: Up to approximately 44 months

  4. Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan

    Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan.

    Measured: At designated time points (up to ~44 months)

  5. Trough Concentration (Ctrough) of Patritumab Deruxtecan

    Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan.

    Measured: At designated time points (up to ~44 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start3 Nov 2024
  3. Primary completion7 Dec 2028 (estimated)
  4. Study completion7 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06596694
Sponsor's protocol ID
1022-011
Other IDs
MK-1022-011, 2024-512442-41-00, U1111-1305-0677
Status last verified
Sep 2026
First submitted
11 Sep 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Patritumab deruxtecan in people with Gastrointestinal Cancer, run by Merck Sharp & Dohme LLC at 62 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, China, Australia, Chile, South Korea and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase) (time frame: Up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06596694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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